MYTP01 for Immune-Mediated Diseases

This study is designed to evaluate the clinical value of MYTP01, a traditional Chinese herbal formula developed by clinical experts with the assistance of artificial intelligence (AI), as an adjunct to standard medical treatment for representative immune-mediated conditions (post-kidney transplantation, IgA nephropathy, etc.). The study aims to investigate whether MYTP01 may provide therapeutic benefits across different immune-mediated conditions by modulating shared immune and inflammatory processes. The trial adopts a multicenter, randomized, double-blind, placebo-controlled basket design. Approximately 160 participants are enrolled into two disease-specific cohorts based on their clinical conditions. After screening and baseline assessments, eligible participants within each cohort are randomly assigned in a 1:1 ratio to receive either MYTP01 or a matching placebo in addition to standard medical treatment. All participants continue their standard medical treatment, including immunosuppressive therapy as prescribed, throughout the study period. Participants receive oral MYTP01 or placebo twice daily for 8 weeks, followed by continued follow-up until approximately Day 90. Clinical assessments are performed at predefined time points to monitor clinical outcomes, immune function, and treatment safety. Clinical efficacy is evaluated through changes in estimated glomerular filtration rate (eGFR), 24-hour urinary protein excretion, and traditional Chinese medicine syndrome scores. Potential immunomodulatory effects are further explored by assessing T-lymphocyte subsets and inflammatory cytokines, including IL-2, IL-6, IL-10, TNF-α, and TGF-β, to investigate immune and inflammatory responses across the representative disease cohorts. Standardized clinical and laboratory assessments are performed across participating centers to ensure consistency in data collection and outcome evaluation. Safety is continuously monitored through clinical examinations, routine laboratory testing, and the recording of adverse events throughout the treatment and follow-up periods. The results of this study are expected to provide preliminary clinical evidence regarding the efficacy, safety, and potential immunomodulatory effects of MYTP01 in representative immune-mediated conditions. The findings may also help evaluate the feasibility of AI-assisted traditional Chinese herbal formula development and inform future investigations of shared therapeutic strategies across immune-mediated diseases.